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FDA closes Howard County drug maker

Daily Record, The (Baltimore), May 12, 2008 by Ben Mook

After three years of warnings and inspections, a Howard County drug maker has been effectively shut down by the Food and Drug Administration for reportedly selling untested prescription cough and cold medicine.

The agency secured a permanent injunction against Scientific Laboratories Inc., of Columbia, on Thursday, barring the firm from further drug sales until it complies with the Federal Food, Drug, and Cosmetic Act. The FDA says Scientific Laboratories has been selling drugs that were improperly tested or not tested at all.

Company officials consented to the move, but did not admit or deny the allegations. Philip Katz, with Washington-based Hogan & Hartson LLP, is representing Scientific Laboratories and declined to comment.

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The injunction stemmed from a May 5 lawsuit filed in the U.S. District Court for Maryland against Scientific Laboratories' President Rajeshwari Patel and CEO Amit Roy, who is also known as Kanak Patel. The lawsuit followed a series of inspections and warnings that date back to June 2005.

Telephone calls to a residence listed as being owned by Patel and Roy were not returned Friday.

In the lawsuit, the FDA laid out a list of alleged violations including selling drugs not approved by the agency and not following "current good manufacturing practices," such as keeping proper records and ensuring products were free of objectionable microorganisms.

The 12 drugs named in the lawsuit were sold under brand names including: B-Vex Suspension; Ben-Tann Suspension; D-Tann Suspension; Nazarin Liquid and Duratan DM Suspension. According to the agreement, which Patel and Roy signed, the company has 15 days to destroy its stock of the products.

The FDA also may require Scientific Laboratories to recall its products from the marketplace.

"From the FDA's perspective these drugs are not considered safe and effective," FDA spokeswoman Rita Chappelle said. "We haven't been able to review the labels and directions to see if they could pose a threat."

According to the FDA, the company has been warned repeatedly that it was in violation of the agency's current good manufacturing practices. The FDA last inspected the facility in August 2007 and again noted the violations of the Federal Food, Drug, and Cosmetics Act.

Michael Levy, director of the Division of New Drugs and Labeling Compliance in the Office of Compliance for the FDA's Center for Drug Evaluation and Research, said the agency prefers to work with companies to fix violations before attempting to secure a permanent injunction.

"An injunction is the agency's most severe sanction," he said. "We usually go through several steps to give a firm a chance to come into compliance."

The penalties are steep if Scientific Laboratories does not live up to the decree. In addition to legal and consultant fees and reimbursement to the FDA, the company could be hit with a $5,000-a- day fine.

"If it gets to this point, we've tried to work with the company and this is an action we had to take to ensure public safety," Chappelle said.

Some of the drugs named by the FDA were manufactured for Midlothian Laboratories, a Montgomery, Ala.-based generic drug company. Amity, N.Y.-based Hi-Tech Pharmacal Inc. purchased Midlothian in December 2007.

Christopher LoSardo, vice president of corporate development at Hi-Tech, said the relationship with Scientific Laboratories ended around the same time his company acquired Midlothian. He said Hi- Tech has switched to other manufacturers and expects a recall to have a limited effect on Midlothian.

"Many of these were smaller selling items, with not a lot of inventory," LoSardo said. "I really wouldn't expect this to impact us too much."

FDA closes Howard County drug maker

Daily Record, The (Baltimore), May 12, 2008 by Ben Mook

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